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510(k) K943981

Device
Il Test Phenobarbital Calibrators
Applicant
INSTRUMENTATION LABORATORY CO.
510(k) number
K943981
Product code
DLZ
Decision
Substantially Equivalent (SESE)
Decision date
1995-01-18
Date received
1994-06-07
Regulation
862.3660
Classification name
Enzyme Immunoassay, Phenobarbital
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
WALLIS W CADY
Address
101 Hartwell Ave. Lexington MA US 02421 02421

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K993031ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54Syva Co.2000-01-27
K984288VITROS CHEMISTRY PRODUCTS PHBR SLIDESOrtho-Clinical Diagnostics, Inc.1999-01-26
K946210PHENOBARBITAL ENZYME IMMUNOASSAYDiagnostic Reagents, Inc.1995-02-10
K944932PHENOBARBITAL FLEX REAGENT CARTRIDGEDupont Medical Products1994-12-28
K942501ACE CEDIA PHENOBARBITAL ASSAYSchiapparelli Biosystems, Inc.1994-10-06
K935568PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORSBaxter Diagnostics, Inc.1994-03-11
K913190EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORSSyva Co.1991-08-26
K910355IL PHENOBARBITAL ASSAY SYSTEMInstrumentation Laboratory CO1991-04-03